Clinical Trial

This tutorial will define and discuss clinical trials by focusing specifically on:

1. Clinical Trials
2. Informed Consent

1. CLINICAL TRIALS

Clinical trials are a very specialized form of an experiment. They're done on humans. And they're commonly used to test medicine.

Clinical trials are typically the last step before bringing a drug to market. They can be very time consuming and very expensive. They can be time consuming because different levels of the clinical trial might take years. The longer it goes, the more expensive it can get.

• Clinical Trial
• An experiment where a pharmaceutical company or government agency tests the safety and efficacy of an experimental drug, medical device or therapy for human use.

IN CONTEXT

Suppose you work for pharmaceutical company and they want to try out a newly adopted drug. The only way this can be achieved is by testing it on people.

You are in charge of testing the overall safety and the maximum achieved response of the drug. The company wants you to find the answers to the following questions:

Is it safe?
Does it work?

It’s very important that you get it right. The pharmaceutical company stands to make a lot of money on an approved drug and a lot to lose if the drug harms people. It will be important to get informed consent from all participants, so they know the possible benefits and more importantly, risks.

2. INFORMED CONSENT

Because participants in clinical trials are human beings, it’s important to be careful about communicating risks. Clinical trials are conducted because all possible side effects are not known. In other words, there are risks along with the potential benefits of a clinical trial. When a person agrees to be in a clinical trial, they have to be made aware of the benefits and the risks.

Researchers make participants aware of benefits and risks, and then have the participants sign a document. This is called informed consent.

Benefits

• Gaining access to new research treatments before they're widely available
• Expert medical care at the leading health care facilities
• Hope is given to those at the end of the road with current treatments
• Help others with the same condition by participating in medical research

Risks

• Side effects might be very unpleasant or even life-threatening
• Treatment might not even work
• A patient must agree to the benefits and risks before a clinical trial can begin

Clinical trials are designed to help drug companies and government agencies to decide whether or not a drug is safe and effective. There are benefits, such as receiving access before it is released worldwide. However, potential risks can be life-threatening. Because of the possible risks, all participants must provide informed consent, which is a way of accepting the possible risks.

Good luck!